25 results · 27ms · Sources: EU EUDAMED, US FDA

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INTEGRA TITANIUM BONE WEDGE

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517574701·CoRoent Ant TLIF Ti, 13x11x36mm 0°

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605022·SPACER 2131360 OLIF25 27MM 6 DEG 12X60

ArgenIS

FDA UDI
ARGEN CORPORATION, THE·D818131360·TiBase Screw AO RP

OsteoMed

FDA UDI
OSTEOMED LLC·00845694046152·PrimaLIF LLIF PEEK Implant, 13mm X 22mm X 60mm,...

SHEAUMANN PL-980

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

GI SUPPLY BILIARY STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 16, 2020

EXC ABT RNGLC-X SHELL PC 060MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code JDI·March 1, 2021

GMK-PRIMARY FEMUR PS CEMENTED SIZE 4

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2019

GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017

GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2018

DIAMOND II

FDA Adverse Event
Injury ·MEDTRONIC S.A.·Product code DXY·June 16, 2011

HEARTMATE II LVAS

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·May 23, 2013

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code IOR·October 1, 2014

OT VERIO2 METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

FDA Enforcement
Class III ·Terminated·Ultradent Products, Inc.·March 6, 2013

Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

FDA Enforcement
Class I ·Ongoing·Abbott Vascular·May 25, 2022

RESOLUTE INTEGRITY RX

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code NIQ·October 19, 2018

BIOMET HIP SYSTEM MODULAR HEAD COMPONENT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 19, 2017